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Clinical Research Plan for Human Myopia Models

Clinical Research Plan for Human Myopia Models

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06185868
Enrollment
2000
Registered
2023-12-29
Start date
2022-05-01
Completion date
2022-10-30
Last updated
2023-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Myopia Model

Brief summary

Collect optical biological parameters, refractive index data, and other related parameters of myopia and refractive errors in children and adolescents, and establish an optical model of myopia in children and adolescents.

Detailed description

Experimental research purpose:Collect optical biological parameters, refractive index data, and other related parameters of myopia and refractive errors in children and adolescents, and establish an optical model of myopia in children and adolescents. Case selection: This study requires the inclusion of children and adolescents aged between 4 and 18 years who have been diagnosed with myopia and refractive errors through medical examination of dilated pupils. Plan: Collect eye parameters such as refractive power, whole eye aberration, corrected visual acuity, pupil diameter, axial length, anterior and posterior corneal surface curvature, and corneal thickness of all subjects under 9 non dilated stimuli.

Interventions

No intervention measures

Sponsors

Robotrak Technologies Co., Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

Selection criteria: 1. Gender unlimited 2. Age 6-16 years old 3. Through medical optometry with dilated pupils, the spherical equivalent refractive index is within the range of -0.5DS\ -8.0DS, and the cylindrical lens is ≤ -0.75DC

Exclusion criteria

1. Patients with corneal diseases such as corneal ulcers, corneal opacities, and corneal leukoplakia 2. Patients with refractive media opacity, such as cataracts and vitreous hemorrhage 3. Glaucoma patients 4. Patients with nystagmus 5. Patients with strabismus and amblyopia 6. Patients with fundus diseases 7. Patients with a column mirror range greater than -0.75DC 8. Patients with binocular anisometropia ≥ 1.0D 9. Corneal contact lenses (such as corneal reshaping lenses, multifocal contact lenses, and RGP) with a history of wearing 10. Long term history of low concentration atropine and other ocular medications 11. Wearing history of functional lenses such as asymptotic multifocal, multi-point myopic defocus, peripheral defocus, etc 12. Patients participating in other eye clinical trials 13. Individuals with mental illness or cognitive impairment who are unable to cooperate * Researchers believe that other reasons are not suitable for clinical trial participants, such as poor physical condition on the day of the trial

Design outcomes

Primary

MeasureTime frameDescription
Refraction7 monthsUnits of measurement:Diopter; measurement tool: subjective refraction;
Whole eye aberration7 monthsUnits of measurement:micorn; measurement tool: Visual quality analyzer;
Pupil diameter7 monthsUnits of measurement:millimetre; measurement tool Visual quality analyzer;
Eye axis length7 monthsUnits of measurement:millimetre; measurement tool: IOLMaster 700(ZEISS)
Corneal anterior and posterior surface curvature7 monthsUnits of measurement:Diopter; measurement tool: Petacam HR
Corneal thickness7 monthsUnits of measurement:millimetre; measurement tool: Petacam HR
Anterior Chamber Depth7 monthsUnits of measurement:millimetre; measurement tool: Petacam HR
Corrected Visual Acuity7 monthsUnits of measurement:NA; measurement tool: subjective refraction;
Intraocular Pressure7 monthsUnits of measurement:millimeters of mercury height; measurement tool: Tonometer (NT-510)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026